CMS SOM App. Z, Tag E-0001

§485.68, §485.625, §485.727, §485.920, §486.360, §491.12

The [facility, except for Transplant Programs] must comply with all applicable

Federal, State and local emergency preparedness requirements. The [facility, except

for Transplant Programs] must establish and maintain a [comprehensive] emergency

preparedness program that meets the requirements of this section.* The emergency

preparedness program must include, but not be limited to, the following elements:

* (Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this

Appendix refers to all provider and suppliers addressed in this appendix. This is a

generic moniker used in lieu of the specific provider or supplier noted in the regulations.

For varying requirements, the specific regulation for that provider/supplier will be noted

as well.)

*[For hospitals at §482.15:] The hospital must comply with all applicable Federal,

State, and local emergency preparedness requirements. The hospital must develop

and maintain a comprehensive emergency preparedness program that meets the

requirements of this section, utilizing an all-hazards approach. The emergency

preparedness program must include, but not be limited to, the following elements:

*[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State,

and local emergency preparedness requirements. The CAH must develop and

maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be

limited to, the following elements:

Interpretive Guidelines applies to: §403.748, §416.54, §418.113, §441.184, §460.84,

§482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920,

§486.360, §491.12.

NOTE: This does not apply to Transplant Programs.

NOTE: The word comprehensive is not used in the language for ASCs.

NOTE: The emergency preparedness program and its elements must be reviewed and

updated annually for LTC facilities at §483.73(a). We’ve identified the differences in

regulatory text for LTC facilities.

Under this condition/requirement, facilities are required to develop an emergency

preparedness program that meets all of the standards specified within the

condition/requirement. The emergency preparedness program must describe a facility's

comprehensive approach to meeting the health, safety, and security needs of their staff

and patient population during an emergency or disaster situation. The program must also

address how the facility would coordinate with other healthcare facilities, as well as the

whole community during an emergency or disaster (natural, man-made, facility). The

emergency preparedness program must be reviewed every two years for all providers and

suppliers, with the exception of LTC providers who must review their emergency

program annually. All facilities are expected to make the appropriate changes to their

emergency program in the event changes are required more frequently outside of their

update cycles. (“Medicare and Medicaid Programs; Regulatory Provisions To Promote

Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for

Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To

Promote Innovation, Flexibility, and Improvement in Patient Care” Final Rule, 84 FR

51732, 51735, Sept. 30, 2019) (“Burden Reduction Rule”).

A comprehensive approach to meeting the health and safety needs of a patient population

should encompass the elements for emergency preparedness planning based on the “all-hazards” definition and specific to the location of the facility. For instance, a facility in a

large flood zone, or tornado prone region, should have included these elements in their

overall planning in order to meet the health, safety, and security needs of the staff and of

the patient population. Additionally, if the patient population has limited mobility,

facilities should have an approach to address these challenges during emergency events.

The term “comprehensive” in this requirement is to ensure that facilities do not only

choose one potential emergency that may occur in their area, but rather consider a

multitude of events and be able to demonstrate that they have considered this during their

development of the emergency preparedness plan. As emerging infectious disease

outbreaks may affect any facility in any location across the country, a comprehensive

emergency preparedness program should include emerging infectious diseases and

pandemics during a public health emergency (PHE). The comprehensive emergency

preparedness program emerging infectious disease planning should encompass how

facilities will plan, coordinate and respond to a localized and widespread pandemic,

similar to what is occurring with the 2019 Novel Coronavirus (COVID-19) PHE.

Facilities should ensure their emergency preparedness programs are aligned with their

State and local emergency plans/pandemic plans.

Documentation and Requirements

The emergency preparedness program must be in writing. The requirements under the

emergency preparedness Final Rule allow for documentation flexibility. While facilities

are required to meet all of the provisions applicable to their provider/supplier type, how

they document their efforts is subject to their discretion. We are not requiring a hard

copy/paper, electronic or any particular system for meeting the requirements. It is up to

each individual facility to be able to demonstrate in writing their emergency

preparedness program. We would also recommend, but are not requiring, facilities to

develop a crosswalk as applicable for where their documents are located. For instance,

if their emergency plan is located in a binder, specify this for surveyors. If there are

policies and procedures to specific standards/requirements, identify where these are

located.

Providers and suppliers are encouraged to keep documentation and their written

emergency preparedness program for a period of at least 2 years for inpatient providers

and at least 4 years for outpatient providers. We are recommending this process due to

the requirements related to training and testing exercises. Inpatient providers are

required to have 2 exercises per year, therefore surveyors will review the current year

and the previous year to determine compliance. For outpatient providers, testing

exercises are required annually, however require full-scale exercises every other year,

with the opposite years allowing for the exercise of choice. In order to determine

compliance, surveyors will be required to review at least the past 2 cycles (generally 4

years) of emergency testing exercises.

Additionally, we are not requiring approval of the Emergency Program or official “sign-off,” however, we do recommend facilities check with their State Agencies and local

emergency planning coordinators (LEPCs) as some states require approval of the

emergency preparedness plans as part of state licensure.

Survey Procedures

• Interview the facility leadership and ask him/her/them to describe the facility’s

emergency preparedness program.

• Ask to see the facility’s written policy and documentation on the emergency

preparedness program.

• For hospitals and CAHs only: Verify the hospital’s or CAH’s program was developed

based on an all-hazards approach by asking their leadership to describe how the

facility used an all-hazards approach when developing its program.